Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54193–54216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2009
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
K083456 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 101d
Cleared Mar 02, 2009
REEKROSS FAMILY OR OTW PTA CATHETERS
K083596 · DQY
ClearStream Technologies , Ltd.
Cardiovascular · 87d
Cleared Mar 02, 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · KTT
Sterilmed, Inc.
Orthopedic · 83d
Cleared Mar 02, 2009
PHOGLASS CEM
K083766 · EMA
S & C Polymer GmbH
Dental · 74d
Cleared Feb 27, 2009
TIGER DISCECTOMY DEVICE
K081240 · HRX
Spinal Devices, LLC
Orthopedic · 302d
Cleared Feb 27, 2009
GLUCODR PLUS SYSTEM, MODEL AGM-3000
K082328 · NBW
All Medicus Co., Ltd.
Chemistry · 197d
Cleared Feb 27, 2009
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 165d
Cleared Feb 27, 2009
PROTRON TECHNOLOGIES, LLC STETHOTRON
K082771 · DQD
Protron Technologies, LLC
Cardiovascular · 158d
Cleared Feb 27, 2009
EYE SPHERES
K082850 · HPZ
Product and Educational Services, LLC
Ophthalmic · 151d
Cleared Feb 27, 2009
NIM 3.0
K083124 · GWF
Medtronic Xomed, Inc.
Neurology · 128d
Cleared Feb 27, 2009
MEDILED PHOTOTHERAPY LAMP
K083179 · LBI
Medix I.C.S.A.
General Hospital · 122d
Cleared CT Feb 27, 2009
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS:...
K083395 · DXN
Andon Health Co, Ltd.
Cardiovascular · 102d
Cleared Feb 27, 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462 · JIT
Siemens Healthcare Diagnostics
Chemistry · 95d
Cleared Feb 27, 2009
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA...
K083465 · CGS
Siemens Healthcare Diagnostics
Chemistry · 95d
Cleared Feb 27, 2009
BIOCRYL X
K083479 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 95d
Cleared Feb 27, 2009
AVS TL PEEK SPACERS
K083661 · MAX
Stryker Corp.
Orthopedic · 79d
Cleared Feb 27, 2009
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT...
K083680 · CEM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 77d
Cleared Feb 27, 2009
ERBIUM FRACTIONAL HANDPIECE
K083900 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 60d
Cleared Feb 27, 2009
CONCERTO DETACHABLE COIL SYSTEM
K090046 · KRD
Micro Therapeutics, Inc.
Cardiovascular · 51d
Cleared Feb 27, 2009
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
K090238 · KPR
Sedecal., Sa.
Radiology · 25d
Cleared Feb 27, 2009
IMAG, IPOD, EZ-FIND AND ISLIDE
K090362 · LRX
Voguestrap
Ophthalmic · 14d
Cleared Feb 27, 2009
PRODRIVE LINE OF DENTAL HANDPIECES
K090369 · EFB
Prodrive Systems, Inc.
Dental · 14d
Cleared Feb 27, 2009
ATMOS C361/C451 SUCTION PUMP
K090445 · BTA
Atmos, Inc.
General & Plastic Surgery · 7d
Cleared Feb 26, 2009
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532 · KZE
Pharmajet, Inc.
General Hospital · 269d